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Document Coordinator

Reference:SGABYN-338165 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Document Coordinator

Life Science recruitment are souring a Document Coordinator for a Global Device Development Organisation who are focused on the design, development and commercialisation of a diverse portfolio of device technology solutions globally. These device technologies enable drug-delivery for respiratory, biologic, biosimilar and injectable products.

Roles & Responsibilities

• The successful candidate will join the Global Device Development team as the Global Device Development Documentation Coordinator collaboration with our clients QA function, Legal and training departments.
• Lead the document control discipline in the group by providing technical support in documenting and maintaining the GDD Documentation Management System (Documentum) through knowledge and understanding of Good Documentation Practices.
• Support the filing documents on-line, routing for approvals and follow ups to ensure approvals are completed in a timely manner.
• Responsible for the documentation system, ensuring procedures comply with internal requirements including tabulating periodic reviews of the status of documents in the Documentation Management System.
• Assigning document numbers as requested by the project team.
• Participate, input and present in project/ department meetings as required
• Locate and resolve data input errors and anomalies.
• Processing all “for information” requests and distribution of information to the project team.
• Become the Global Device Development (GDD) point of contact for the in house Legal team- supporting the progress of contracts and service agreements.
• Have ownership of GDDs Training plans, including training coordination and management.

Skills & Qualifications

• Experience as a Documentation Coordinator/ Controller, using on-line platforms in a controlled environment such as Pharmaceutical or Medical device with demonstrable experience.
• Experience within a medical device and/or pharmaceutical company as a documentation controller would be a distinct advantage.
• Experience of compliance within Quality Management systems for documentation management.
• Excellent technical report writing skills and systematic approach to filing necessary.
• Proven track record in file management and documentation coordination, with experience in electronic filing systems.
• Awareness of ISO13485 and 21 CFR 820 an advantage.
• Experience of taking ownership and responsibility of documentation management systems.
• Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established time lines.

If you would like further Information you can contact the recruiter directly:

Simon Gillivan | Tel: +353 (0) 1 507 9258